Safety & Efficacy of Daily CF101 Administered Orally in Subjects With

Status Completed

Clinical Trial Summary

This study will test the hypothesis that CF101, administered orally, will reduce intraocular pressure in patients with ocular hypertension and/or glaucoma. Eligible patients with elevated intraocular pressure will be evaluated and treated by ophthalmologist investigators, and will receive either CF101 pills or placebo (dummy) pills twice daily for 16 weeks. Ocular pressure, visual fields, and other aspects of safety and effectiveness will be monitored on a regular basis.

Clinical Trial Description

This is a Phase 2, randomized, double-masked, placebo-controlled, parallel-group study in adult males and females, aged 18 years and over, with a diagnosis of glaucoma or ocular hypertension. This trial will be performed in 2 segments. In Segment 1, subjects will be randomized to receive either CF101 1.0 mg, or matching placebo, given orally every 12 hours for 16 weeks. Segment 1 will enroll approximately 44 subjects, randomized in a 3:1 ratio to CF101 1.0 mg or to placebo. At the conclusion of Segment 1, a Data Review Committee (DRC) will review safety and efficacy data and advise on progression of the trial to Segment 2. Segment 2 will enroll up to approximately 44 subjects randomized in a 3:1 ratio to CF101 2.0 mg 3:1 ratio to receive with CF101 2.0 mg, or matching placebo, given orally every 12 hours for 16 weeks. At a Screening Visit (Visit 1, performed within 4 weeks prior to Baseline), subjects who provide written informed consent will have screening procedures performed, including complete medical, ophthalmologic, and medication histories; physical examination; vital signs and weight; electrocardiogram (ECG); ophthalmologic examination; tonometry; visual field (VF) assessment; corneal pachymetry; evaluation of inclusion and exclusion criteria; safety laboratory tests; serum pregnancy test for all females of child-bearing potential; and collection of concomitant medication information. Subjects who successfully qualify will be randomized at Baseline (Visit 2) to their assigned medication (CF101 or matching placebo) to be taken orally every 12 hours for 16 weeks. Subjects will return for assessments and a new supply of study medication at Weeks 2, 4, 8, 12, and for final assessment and discharge at Week 16. A safety telephone call will be made at Week 18. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01033422
Study type	Interventional
Source	Can-Fite BioPharma
Contact
Status	Completed
Phase	Phase 2
Start date	October 2010
Completion date	April 2017

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06000865` - Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE	N/A
Recruiting	`NCT06278597` - Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device	N/A
Active, not recruiting	`NCT04271709` - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)	N/A
Recruiting	`NCT03274024` - The Asia Primary Tube Versus Trab (TVT) Study	N/A
Completed	`NCT04552964` - Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma	N/A
Recruiting	`NCT01957267` - Functional and Structural Imaging for Glaucoma
Active, not recruiting	`NCT04624698` - iStent Inject New Enrollment Post-Approval Study	N/A
Completed	`NCT04020705` - The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma	N/A
Completed	`NCT03150160` - Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma	Phase 4
Not yet recruiting	`NCT05581498` - Glaucoma Exercise as Medicine Study (GEMS).	N/A
Recruiting	`NCT02921568` - Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes	N/A
Active, not recruiting	`NCT02901730` - Clinical Study of LPI With Different Laser Wavelengths	N/A
Completed	`NCT02955849` - A Trial of China Laser and Surgery Study Glaucoma in Rural China	Early Phase 1
Recruiting	`NCT02554214` - Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device	N/A
Recruiting	`NCT02471105` - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml	Phase 4
Active, not recruiting	`NCT02390284` - Stop Retinal Ganglion Cell Dysfunction Study	Phase 3
Completed	`NCT02390245` - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study	N/A
Completed	`NCT02246764` - Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension	Phase 3
Completed	`NCT02653963` - Triamcinolone for Ahmed Glaucoma Valve	N/A
Completed	`NCT02628223` - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Safety and Efficacy of Daily CF101 Administered Orally in Subjects With Elevated Intraocular Pressure

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms